PRoFESS
Prevention Regimen For Effectively avoiding Second Strokes
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Status:
Completed. As of July 2006, 20333 had been enrolled. Data is being analyzed.
This study has been completed.
Purpose:
To compare the efficacy and safety of Aggrenox®(25 mg aspirin/200 mg extended-release dipyridamole) with Clopidogrel (Plavix®), and to compare Micardis® (telmisartan) with placebo in in the presence of background anti-hypertensive treatment in the prevention of recurrent stroke.
Location(s):
35 different countries.
Year Started:
2003
Year Finished:
2006
Design:
Randomised, parallel group, multi-national, double-blind, double-dummy, placebo controlled study.
Inclusion Criteria
Age ≤55 years, having had an ischemic stroke within 90 days prior to study entry, or age >50 years and having had an ischemic stroke within 120 days prior to study entry, along with having at least two of the following risk factors:
• Diabetes mellitus
• Hypertension (SBP ≥140 or DBP ≥90 mmHg)
• Smoker at time of qualifying stroke
• Obesity (BMI>30)
• Vascular damage (stroke, myocardial infarction, or peripheral artery disease) prior to qualifying stroke
• End-organ damage (retinopathy, left-ventricular hypertrophy, or microalbuminuria)
• Hyperlipidemia
• Neurologically and clinically stable.
Exclusion Criteria
Patients with hemorrhagic stroke or unstable angina. Patients who are bedridden, have dementia or are unable to give informed consent. Also, patients who are scheduled for surgery, have a history of thrombocytopenia or neutrapenia.
Patient Involvement:
18,500 patients will be randomized into one of four treatment groups, in a 2 by 2 factorial design. All patients receive active antiplatelet medication, either clopidogrel or extended-release dipyridamole + aspirin. In addition, half of the patients in each antiplatelet arm will receive telmisartan (an angiotensin receptor blocker or ARB), and half will receive a telmisartan placebo. All hypertensive patients receive open-label antihypertensive medications (such as diuretics, calcium channel blockers, or beta blockers) if necessary to control blood pressure, in addition to the blinded study medication. All study subjects will recieve a physical examination with neurological assessments and study medication for up to 4 years.
Primary Outcome:
Time to first recurrent stroke.
Secondary Outcome:
Composite endpoint of vascular events (first non-fatal stroke, non-fatal MI, vascular death). Composite endpoint of other designated vascular events (time to first PE, retinal vascular accident that is not a retinal arterial occlusion, DVT, peripheral arterial occlusion, and stroke type).
Results:
20,332 patients (mean age 66 years) were randomised and followed-up for a median of 2.4 years. Recurrent strokes occurred in 916 (9%) patients randomly assigned to ASA with ER-DP and 898 (9%) patients randomly assigned to clopidogrel; 880 (9%) patients randomly assigned to telmisartan and 934 (9%) patients given placebo had recurrent strokes. mRS scores were not statistically different in patients with recurrent stroke who were treated with ASA and ER-DP versus clopidogrel (p=0.38), or with telmisartan versus placebo (p=0.61). There was no significant difference in the proportion of patients with recurrent stroke with a good outcome, as measured with the Barthel index, across all treatment groups. Additionally, there was no significant difference in the median MMSE scores, the percentage of patients with an MMSE score of 24 points or less, the percentage of patients with a drop in MMSE score of 3 points or more between 1 month and the penultimate visit, and the number of patients with dementia among the treatment groups. There were no significant differences in the proportion of patients with cognitive impairment or dementia among the treatment groups. Disability due to recurrent stroke and cognitive decline in patients with ischaemic stroke were not different between the two antiplatelet regimens and were not affected by the preventive use of telmisartan.
Source of Information:
PRoFESS Study Web Site. Presented at the 30th International Stroke Conference (February 2005).
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This information last updated on: 5/20/2009
Reviewed on: 05/20/2009.
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